Paladin Medical® wrote the book on 3D printed medical devices.
Well, not the book exactly, but the first 510(k) for a 3D-printed medical device.
Paladin Medical secured the Stratasys FDM MedModeler 510(k) #971290 as a radiological accessory. Medical devices produced by 3D (additive) Manufacturing are the next big thing. But the US FDA issued a guidance on December 5, 2017: Technical Considerations for Additive Manufactured Medical Devices; and they have a lot to say. If you are considering employing 3D manufacturing in any capacity for a medical device, including making changes to an existing device for which you might already have a 510(k), you need to contact Paladin Medical, Inc. early in your planning.
The December 2017 guidance speaks to FDA’s recommendations for testing and characterization for devices that include at least one additively manufactured component or additively fabricated step. This is a very important distinction. Even if your device only has a PART or a PROCESS STEP that involves 3D printing and you need to know what is in this guidance and how the guidance would affect the contents of your 510(k) submissions.
The guidance is divided roughly into two areas: Design/Manufacturing and Device Testing. The former considers quality system requirements and the latter is concerned with testing (and application content). FDA considers that this guidance should be viewed as a supplement to any device-specific recommendations or FDA recognized standards. This guidance DOES NOT address manufacturing using biological, cellular or tissue-based materials. Such materials would necessitate additional regulatory considerations. Suffice it to say, such products are going to require a good deal of head-scratching by FDA, as well as several different departments involved. 3D printing technology is not new to FDA, in fact they held a public workshop in 2014 to discuss the many challenges. FDA’s considers that the very attributes which make 3D printing attractive (such as making patient matched devices from images and tortuous internal channels) pose challenges for assessing the final finished device.
Just as with any medical device the information, characterization and testing FDA will need to see in a submission will be dependent on how the device is used (intended use) and the risks associated with the use. FDA gives us a hint for future submissions: determine and justify which of their “considerations” are appropriate for your device based on the material and technology being used. FDA acknowledges that a 3D printed device would likely follow the same regulatory path as a non-AM device, but if the 3D processes raise different questions or safety and/or effectiveness the applicant could be in for a surprise, and thus recommends a PRESUB meeting. Another “hint” FDA provides for the content of a submission is to present how the 3D printing plays a role in the device, including how software is involved. It is also wise to try to conform to FDA’s definitions in a submission. These little tricks of the regulatory trade can smooth communication.
Future posts on this subject will break down FDA’s concerns into bite size pieces. We’ll discuss whether or not putting 3D printing into an existing device could trigger a new 510(k), how 3D printing is a concern for Device (Design) Validation, and how important the evaluation of materials (and materials processing methods) could be to a successful FDA clearance.